Document pK50OwQ87ddZG1gX2dy9dbVX

/^/C . O- 1423S NOTICES the denial order issued against the re spondent on February 28. 1972 (37 FR 5306J. Dated: April 12.1976. Ratter H. Meyer, Director, Office of Export Administration. [FR Doc.74--9080 Filed 4-19-74;8:45 am) COMPUTER SYSTEMS TECHNICAL ADVISORY COMMITTEE dressed to: Central Reference and Rec ords Inspection Facility, U8. Depart ment of Commerce, Washington, D.C. 20230. Dated: April 17.1974. Rapes H. Meyer, Director, Office of Export Ad ministration, Bureau of EastWest Trade, Department of Commerce. (FR Doc.74-9099 Filed 4-19-74:8:45 am] Notice of Meeting DEPARTMENT OF HEALTH, Pursuant to the provisions of the Fed EDUCATION, AND WELFARE eral - Advisory Committee Act (Public Lair 32-463), notice is hereby given that a meeting of the Licensing Procedures Food and Drag Administration (NADA No. 48-23GV] Subgroup of the Computer Systems Technical Advisory Committee will be held Monday, April 29, 1974, at 1:30 p.m. in Conference Room A, Main Com AGRITRONICS CORP. Agritronics Swine Premix T-S; Withdrawal of Approval of New Animal Drug Application merce Building, 14th and Constitution Pursuant to provisions of the Federal Avenue, Washington, D.C. Food, Drug, and Cosmetic Act (sec. 512. Members advise the Office of Export 82 Stat. 343-351; 21 U.S.C. 360b) and Administration, Bureau of East-West under authority delegated to the Com Trade, with respect to questions involv missioner of Food and Drugs (21 CFR ing technical matters, worldwide avail 2.120), the following notice is issued: ability and actual utilization of produc tion and technology, and licensing pro cedures which may aficct the level of export controls applicable to computer systems, including technical data re lated thereto, and including those whose export is subject to multilateral(COCOM) controls. Agenda items are as follows: Agritronics Corp., 811 24th St., Des Moines, IA 50311, has requested that its NADA (new animal drug application) No. 48-236V be withdrawn is accordance with 135.28(d) .(21 CFR 135.28(d)) on the grounds that the drug is not being marketed. Notice is given that approval of NADA No. 48-236V for Agritronics Swine Premix T-S, which contains ty- 1. Opening remarks by tbc Chairman, losin and sulfamethazine, is hereby Computer Systems Technical Advisory withdrawn. Committee. 2 Appointment of subgroup chairman. Effective date. This notice shall be ef 3. Presentation of papers or comments by fective April 22,1974. the public. 4. Discussion of export licensing proce Dated: April 15.1974. dures relating to computer systems. 5. Executive Session: Continuation of dis cussion of export licensing procedures. Sam D. Fine, Associate Commissioner for Compliance. The public will toe permitted to attend the discussion of agenda items 1-4, and (FR Doc.74-9114 Filed 4-l9-74;8:45 am] a limited number of seats will be avail able to the public for these agenda items. To the extent time permits, members of the public may present oral statements HUMAN DRUGS CONTAINING VINYL CHLORIDE OR PACKAGED IN POLY VINYL CHLORIDE CONTAINERS to the subgroup. Interested persons are Notice to Drug Manufacturers, Packers, also invited to file written statements and Distributors with the subgroup. With respect to agenda Item 5, "Exec utive Session," the Assistant Secretary of Commerce for Administration, on De cember 20, 1973, determined, pursuant to section 10(dl of Public Law 92-463, that this agenda item should be exempt from the provisions of sections 10 (a) (1) and <al(31, relating to open meetings and public participation therein, because the meeting will be concerned with mat ters listed in 5 U.S.C. 552(bl(l). Further information May be obtained from John L. Collins, Chairman, Com puter Systems Technical Advisory Com mittee, IBM World Trade Corporation, 1801 K Street NW., Washington, D.C. 20006 (A/C 202-833-6000). Elsewhere in this issue of the Federal Register (39 FR 14215) the Commis sioner of Food and Drugs has proposed that all aerosol drug products containing vinyl chloride as a component, including prope'lant, are new drugs and subject to regulatory proceedings unless the prod ucts are the subject of new drug appli cations approved pursuant to section 505 of the Federal Food, Drug, and Cosme tic Act. That proposal is based on scien tific data demonstrating that vinyl chlo ride is not generally recognized as safe and effective as a component, including propellant, of a drug product. The Food and Drug Administration is aware that vinyl chloride has been used as a propellant in aerosol drug prepara Minutes of those portions of the meet tions, but has no information that vinyl ing which are open to the public will chloride is currently being used in the be available 30 days from the date of manufacture of drug products. There is the meeting upon written request ad- ample evidence that vinyl chloride In undation can result in acute toxicity manif ested by an array of symptoms In cluding unconsciousness as a result of high concentration inhalation. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys have also been reported In animals. In addition, there are studies demonstrat ing the carcinogenic effects In animals as a result of inhalation exposure to vinyl chloride, and it has been linked to liver disease, including liver cancer, in work ers engaged in the polymerization of the monomer to polyvinyl chloride. Polyvinyl chloride, a polymeric resin produced by polymerization of vinyl chloride, is used in drug packaging materials. There is evidence of vinyl chloride migration when polyvinyl chlo ride is used in packaging material for products containing alcohol. There have also been reports of the possible migra tion of polyvinyl chloride container ingredients to non-alcoholic products as well. Because of this it is necessary to give special study to such packaging material to determine if it is safe for its intended use. For these reasons it is essential that the Commissioner have knowledge of every drug product currently marketed in the United States that contains vinyl chloride as an ingredient, and informa tion regarding every marketed drug product packaged in a polyvinyl chloride container or in a container lined with polyvinyl cldoride. Such information is necessary for determining if there is ade quate evidence whether drugs containing vinyl chloride or packaged in containers composed of, or lined with, polyvinyl chloride are safe and effective for their intended purposes and what action, if any, is required to protect the public health. Section 5l0(j)(3) of the act, as added by the Drug Listing Act of 1972, author izes the Commissioner to require each registrant under section 510 of the act to submit a list of each drug product which the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution and which contains a particular ingredi ent, when the Commissioner has made a finding that the submission of such a list is necessary to carry out the pur poses of the act. For the reasons stated above the Commissioner so finds with regard to drugs containing vinyl- chlo ride. As packaging materials are an integral part of the drug product, the Commissioner also so finds with regard to drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners. In addition to the required list of drugs containing vmyl chloride and a required list of drug products packaged in poly vinyl chloride containers or in containers with polyvinyl chloride liners, the Com missioner is requesting, but not requir ing, that certain other information be submitted. The Commissioner acknowl edges that some of the information being requested has also been requested In the regulations implementing the Drug List ing Act of 1972, and will be available FEDERAl REGISTER, VOL 39, NO 78--MONDAY, APRIl 22, 1974 02184 CUSARSS NOTICES 14239 from that source. However, It will greatly simplify the compilation of this Infor mation If It is included in this sub mission. Therefore, pursuant to the provisions of the Federal Food. Drug, and Cosmetic Act (secs. 201, 510, 701(a). 52 Stat. 10401042, as amended, 1053, as amended, 1055, as amended; 21 U.S.C. 321. 360, 371(a); 42 U.S.C. 262) and under au thority delegated to the Commissioner (21 CFR 2.120), each registrant under section 510 of the act is required to sub mit to the Food and Drug Administra tion a list of all human drugs which are being manufactured, prepared, propa gated, compounded, or processed for commercial distribution and which con tain vinyl chloride whether or not the vinyl chloride is an active or inactive in gredient and a list of all human drug products packaged in polyvinyl chloride containers or in containers with poly vinyl chloride liners as follows: 1. Reporting firm name, address, and registration number. 2. List of drugs containing vinyl chloride (by trade name, if any. and established name, if any) and a list of drug products for which polyvinyl chloride is used as a con tainer or a container liner (by trade name, if any, and established name, if any). It is requested but not required that the following information also be sub mitted: 3. National Drug Code (NDC) If one has been assigned. 4. A statement whether the drug A mar keted over the counter or limited to pre scription distribution. 6. Route of administration. 6. Amount of vinyl chloride In average dally dose. 7. Quantity of drug distributed (number of dosage units) during previous 12 months. 8. A copy of the label and labeling. In addition to the information requested in items 1 through 8 (excluding item 6) for drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners it is requested, but not required, that the following in formation be submitted. 9. A statement of the vinyl chloride con tent in polyvinyl chloride uted for the manu facture of the drug container or container lining., Include description of the methods and extraction systems used to determine this content. If this information is not known, provide the name and address of the drug container or container liner supplier and/or manufacturer. 10. The rate and level of extraction of vinyl chloride from the polyvinyl chloride containers or container liners by the particu lar drug or by any other extraction or solvent systems, Including data derived after periods of storage. Where such information is not known, but is or may be available from the supplier or manufacturer of the container or liner, provide the name and address of such supplier or manufacturer. 11. The rate and level of absorption of vinyl chloride as an ingredient or of vinyl chloride extracted from a polyvinyl chloride container or liner by the drug contained on an average daily dose. Where such informa tion is not known, but is or may be available from the supplier or manufacturer of the container or liner, provide the name and address of Buch supplier or manufacturer. 12. Name and address of the manufacturer of the polyvinyl chloride resin, where such information is Known. Committee name Date, time, place Type of meeting end contact person This information shall be submitted to: Department of Health, Education, and Wel fare Food and Drug Administration ____ Bureau of Drugs, Drug Listing Staff (tnn>-7) 6600 Fl3hers Lane Rockville, MD 208S2 by May 22, 1974. 8- Panel oq Review of Dental Devices. May n and 23, 9 a.m.. Amorlean Dental Association Bldg., Chi- c&go, I1L Open May 22, 9 a.m. to 10 &.m., closed May 22 after 10 a,m.. closed May 23. Roberts. Kennedy, Ph.D., ' (TTFM-120) WOO Fishers Lane. Rockville. Md. 20852, 301-443-2376. Dated: April 15, 1974. A. M. Schmidt, Commissioner of Food and Drugs. Purpose. Reviews and evaluates avail able data concerning the safety, effec tiveness, and reliability of dental devices currently in use. (FR Doc.74-9231 Filed 4-19-74:8:45 am] Agenda. Open session: Comments and presentations by interested persons; de ADVISORY COMMITTEES Notice of Meetings Pursuant to the Federal Advisory Com mittee Act of October 6, 1972 (Public Law 92-463, 86 Stat. 770-776: 5 U.S.C. App.), the Pood and Drug Administra tion announces the following public ad visory committee meetings and other re quired information in accordance with provisions set forth in section 10(a) (1) and (2) of the act: vice classification; and device legisla tion. Closed session: Continuing review and classification of dental devices. Agenda items are subject to change as priorities dictate. During the open sessions shown above, interested persons may present relevant Information or views orally to any com mittee for its consideration. Information or views submitted to any committee in writing before or during a meeting shall also be considered by the committee, A list of committee members and sum Committee name Date, time, place Typo of meeting and contact person mary minutes of meetings may be ob tained from the contact person for the committee both for meetings open to the public and those meetings closed to L Panel oit Review of Internal Analgesic Including Anttrheu* mtitle Drugs. May 8 and 9,9 Open May 8, 9 a.m. a.m., Confer to 10 a.m., dosed ence Room C, May 8, after to Farklawn a.m., closed May 9. Bldg,, SG00 Lee Oeismar, Fishers Lane, Room JOB-05, Rockville, 5000 Fishers Lane, Md. Rockville, Md. 20852, 301-443-4960, the public in accordance with section 10(d) of the Federal Advisory Commit tee Act. Most Food and Drug Administration advisory committees are created to ad vise the Commissioner of Food and Drugs on pending regulatory matters. Purpose. Reviews and evaluates avail able Information concerning safety and effectiveness of active ingredients of cur rently marketed non-prescription drug products containing internal analgesic Recommendations made by the commit tees on these matters are Intended to result in action under the Federal Food. Drug, and Cosmetic Act, and these committees thus necessarily participate with the Commissioner in exercising his agents. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuing review of nonprescription internal analgesic drugs law enforcement responsibilities. The Freedom of Information Act rec ognized that the premature disclosure of" regulatory plans, or indeed internal discussions of alternative regulatory ap under investigation. proaches to a specific problem, could Committee name Date, time, place Tyre of meeting and contact person 2, Panel on Review of Orthopeodio Devices May 11.9 a,Tu.. Hotel Utah Motor Lodge, Salt Lake City, Utah. Open 9 a.m. to 10 a.m., closed after 10 a.m, James R, Veale (HFM-120), 5000 Fishers Lane, Rockville, Md, 20852,201-443-3550. have adverse effects upon both public and private interests. Congress recog nized that such plans, even when final ized. may not be made fully available in advance of the effective date without damage to such interests, and therefore provided for this type of discussion to remain confidential. Thus, law enforce ment activities have long been recog nized as a legitimate subject for confi Purpose. Reviews and evaluates avail able data concerning safety, effective dential consideration. These committees often must consider trade secrets and other confidential in ness, and reliability of orthopaedic de formation submitted by particular man vices currently in use. ufacturers which the Food and Drug Agenda. Open session: Comments and Administration by law may not disclose, presentations by interested persons. and which Congress has included within Closed session: Continuation of review of the exemptions from the Freedom of previous classification results and iden Information Act. Such information in tification of specific areas for standards cludes safety and effectiveness informa for those devices classified as requiring tion, product formulation, and manu standards. facturing methods and procedures, all FEDERAL REGISTER, VOL 39, NO. 78--MONDAY, APRIL 22, 1974 > CUSAROSS 02185